Qualicheck Tm

• • Terminated Z-0608-2013 FDA Class III ·initiated 6 Jun 2006 ·on shared 510(k) K771444

  The barcode for the ABL77 on the insert incorrectly enters a control range for pH of 7.90-7.95 into the analyzer. The insert correctly states that the control range is 7.40-7.45.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K771444 ↗

FDA Product Code

JJS

Device Class

Class I

Regulation

21 CFR Part 862.1660

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• ICA1 Ionized Calcium Analyzer

  Class II

  FDA 510(k) K801848 Active Cleared 31 Oct 1980

• Radiomhter Osm-2 Hemoximeter

  Class II

  FDA 510(k) K771263 Active Cleared 3 Aug 1977

• Radiometer Acid Base Laboratory-Abl-3

  Class II

  FDA 510(k) K800224 Active Cleared 22 Feb 1980

• Hemoglobin Check Solutions, S2100 Osm-2

  Class I

  FDA 510(k) K780652 Active Cleared 27 Jul 1978

• TCM202 TCPO2 & TCM204 TCPO2/PO2 Rec. Sy.

  Class II

  FDA 510(k) K802846 Active Cleared 17 Dec 1980

• Acid Base System, Radiometer Automated

  Class II

  FDA 510(k) K760229 Active Cleared 26 Aug 1976